Protective Role of N-acetylcisteine From Cisplatin-induced Ototoxicity in Patients With Head and Neck Cancer

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Introduction. Cisplatin-induced ototoxicity is a very frequent event and its consequences can cause a lot of deterioration in patients. Early diagnosis is essential because it would allow the appropriate implementation of strategies to reduce its effect. Among these N-acetylcysteine, an antioxidant agent that has shown otoprotective effect. Study design. Randomized, parallel design and placebo controlled clinical trial. Methods. Patients with head and neck cancer who require treatment with cisplatin were enrolled in 2 branches: a control group that receives a placebo and experimental group that receives the drug. High-frequency audiometries (6 - 16 KHz) are performed before, during and after the treatment finalization.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital San Juan de Dios, Santiago
• Treatments: Acetylcysteine; Cisplatin; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Adults Patients with Head and Neck Squamous Cell carcinoma requiring Chemoradiotherapy including Cisplatin.

Exclusion Criteria:

• Conductive Hearing Loss

• SNHL with >= 40db PTA